Spinal implant with expandable fixation

ABSTRACT

A spinal implant which is configured to be deployed between adjacent vertebral bodies. The implant has at least one fixation element with a retracted configuration to facilitate deployment of the implant and an extended configuration so as to engage a surface of an adjacent vertebral body and secure the implant between two vertebral bodies. Preferably, the implant is expandable and has a minimal dimension in its unexpanded state that is smaller than the dimensions of the neuroforamen through which it must pass to be deployed within the intervertebral space. Once within the space between vertebral bodies, the implant can be expanded so as to engage the endplates of the adjacent vertebrae to effectively distract the anterior disc space, stabilize the motion segments and eliminate pathologic spine motion. Angular deformities can be corrected, and natural curvatures restored and maintained.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 12/072,044, filed on Feb. 22, 2008, the disclosure of which isincorporated herein by reference.

FIELD OF THE INVENTION

The invention relates to devices and methods for stabilizing thevertebral motion segment. More specifically, the field of the inventionrelates to an expandable spinal implant with fixation elements to fixthe implant within an intervertebral space while providing controlledspinal correction in three dimensions for improved spinal intervertebralbody distraction and fusion.

BACKGROUND OF THE INVENTION

A conventional spine cage or implant is characterized by a kidney beanshaped body which is typically inserted in tandem posteriorly throughthe neuroforamen of the distracted spine after a trial implant creates apathway. Existing devices for interbody stabilization have important andsignificant limitations, including inability to expand and distract theendplates while fixing the device to prevent relative movement betweenthe device and an adjacent vertebral body. Current devices for interbodystabilization include static spacers composed of titanium, PEEK, andhigh performance thermoplastic polymer produced by VICTREX, (Victrex USAInc, 3A Caledon Court; Greenville, S.C. 29615), carbon fiber, orresorbable polymers. Moreover, current interbody spacers do not maintaininterbody lordosis and can contribute to the formation of a straight oreven kyphotic segment and the clinical problem of “flatback syndrome.”Separation of vertebral endplates increases space available for theneural elements, specifically the neural foramen. Existing static cagesdo not reliably improve space for the neural elements. Therefore, whatis needed is a spinal implant that will provide space for the neuralelements posteriorly between the vertebral bodies, or at least maintainthe natural bone contours to avoid neuropraxia (nerve stretch) orencroachment.

Conventional devices for intervertebral body stabilization includes poorinterface between bone and the biomaterial of the device. Conventionalstatic interbody spacers form a weak interface between bone andbiomaterial. Although the surface of such implants is typically providedwith a series of ridges or coated with hydroxyapetite, the ridges may bein parallel with applied horizontal vectors or side-to-side motion. Thatis, the ridges or coatings on the implant offer little resistance tomovement applied to either side the endplates. Thus, nonunion is commonin allograft, titanium and polymer spacers, due to motion between theimplant and host bone.

BRIEF SUMMARY OF THE INVENTION

This invention is generally directed to a spinal implant for insertionbetween superior and inferior vertebral end plates after partial ortotal removal of a spinal disc. The spinal implant embodying features ofthe invention is easily installed and is capable of holding thevertebral or joint sections with increased pullout strength to minimizethe chance of implant fixation loss during the period when the implantis becoming incorporated into the arthrodesis bone block.

More specifically, the invention is particularly directed to a spinalimplant which has one or more extendable fixation elements that engageor penetrate vertebral end plates and prevent movement between theimplant and the vertebral end plates after implantation. The one or moreexpandable fixation elements have a contracted configuration within theimplant so as to not interfere with the insertion of the implant betweenvertebral bodies and have an extended configuration with a distal tipextending beyond the surface of the implant to engage the vertebral endplates after implantation and fix the position of the implant withrespect to the adjacent vertebral body. The fixation element may beextended in a variety of ways such as with fluid pressure, e.g.hydraulic fluid, by mechanical force, such as a threaded connection witha rotating driving member or other suitable means. Fluidic displacementis preferred. The distal tip of the fixation element should be sharpenough to penetrate into the vertebral end plate.

Preferably, the spinal implant embodying features of the invention is anexpandable spinal implant such as the selectively expanding spine cagedescribed in copending application Ser. No. 11/535,432, filed on Sep.26, 2006 and Ser. No. 11/692,800, filed on Mar. 28, 2007, which providesrestoration of disc height between adjacent vertebrae and can providecorrective spinal alignment in a plurality of dimensions. Preferably,the implant has an interior cavity for receiving osteoconductivematerial to promote the formation of new bone in the intervertebralspace subsequent to implanting.

A spinal implant having features of the invention has a base including afirst pressure applying member such as an end plate with a first boneengaging surface, at least one extendable member cooperating with thebase and a second upper pressure applying member with a second boneengaging surface coupled to the at least one extendable member. The oneor more extendable fixation elements are configured to extend throughpassageways provided in the second upper pressure applying member andbeyond the bone engaging surface thereof to penetrate into the adjacentvertebral end plate and fix the implant with respect the vertebral body.Preferably, the fixation elements are slidably disposed within recesseswithin the extendable members.

The selectively expanding spine cage (SEC) or spinal implant embodyingfeatures of the invention is particularly suitable for posteriorinsertion between superior and inferior vertebral end plates asdescribed in the aforementioned copending application Ser. Nos.11/535,432 and 11/692,800. The SEC has an unexpanded configuration whichallows easy deployment and is typically about 0.8 to about 1 cm inmaximum short transverse dimension so as to enable minimal invasiveinsertion posteriorly between vertebral pedicles through a working spaceof approximately 1 cm in diameter. The extended fixation element extendsbeyond the tissue engaging surface of the second pressure applyingmember by at least 0.1 cm, preferably at least 0.25 cm to ensure properengagement or contact with the end plate of the vertebral body andpreferably penetration thereof.

In one preferred embodiment, at least one and preferably all of theextendable members of the SEC have an extendable fixation elementdisposed within a recess in the extendable member. In this embodiment,the implant is preferably fluid activated so the extendable membersexpand the SEC after implantation and be properly positioned between theadjacent vertebral bodies. Additionally, the fixation member is alsoextended by fluid pressure with or after expansion of the SEC.Preferably, the fluid expansion is by hydraulic fluid from a mastercylinder or a syringe located remotely from the patient to enablecontrolled spinal correction in multiple dimensions and fixation of theSEC in a proper position. Individual cylinders or syringes may also beemployed. Advantageously, the hydraulic fluid is a time-controlledcurable polymer, such as methylmethacrylate, which has a viscosity andcuring time that can be adjusted by the formulation of an appropriateadded catalyst, as is well known. When the polymer cures, it hardens andlocks the expanded expandable members and the expanded fixation elementin position to provide the desired amount of anterior/posterior,medial/lateral, superior/inferior spinal correction immovably in place.Mechanical locking of the expandable members and/or the fixationelements may also be employed.

Once inserted between vertebral endplates, the implant advantageouslycan be expanded with a minimum of force exerted remotely through thehydraulic control lines. The expansion of the implant advantageously isabout 20% to about 100% greater than the unexpanded height thereof,typically about 60%. Typical expansion is about 13 mm in the case of a 8mm implant and about 16 mm in the case of a 10 mm implant.

Since the vertebral end plates are held together at one (the anterior)end by a ligament much like a clamshell, as the implant expands againstthe vertebral end plates, the amount of vertical expansion can beadjusted to create the desired anterior/posterior correction angle.

Left and right lateral correction of the spine is achieved bydifferential vertical expansion of the two or more extendable members ofthe implant. Each extendable member is preferably independentlycontrolled by a master cylinder or syringe located ex vivo (away fromthe patient) and communicating hydraulically with the slave cylindersfor moving the pistons and top plate vertically and laterally forcorrecting spinal deformities anteriorly or posteriorly, medial orlateral, thus available to provide spinal correction in threedimensions.

A minimally invasive downsized insertion tool both inserts theunexpanded SEC posteriorly and houses the hydraulic lines communicatingbetween the master cylinder and the slave cylinder. The insertion toolalso houses a line for communicating the liquid or slurry bone graftmaterial to the slave cylinder and into the intervertebral space forsubsequent fusion. Advantageously, the hydraulic lines are small sizetubing to allow for high hydraulic pressure without danger of the linesbursting. The sizes of the slave cylinders and pistons can be varied toincrease the mechanical advantage.

Due to the mechanical advantage provided by the hydraulic system, theSEC has minimized size and diameter in its unexpanded state that issmaller than the diameter of a prepared neuroforamen. The SEC thus canbe inserted posteriorly and is engaged between the endplates of theadjacent vertebra to effectively distract the intervertebral area,restore space for neural elements, stabilize the motion segment andeliminate pathologic segmental motion. The SEC enhances spinearthrodesis by creating a rigid spine segment.

The SEC provides a significant advantage by enabling a comparativelylarge quantity of gone growth conductive or inductive agents to becontained within its interior communicating directly to adjacent bone.Importantly, this results in fixation forces greater than adjacent boneand soft tissue failure forces.

The hydraulic control system provides a minimally invasive procedure byenabling the surgeon to apply a controlling force away from thepatient's body to expand and adjust the spinal implant in threedimensions. Preferably, the expansion is infinitely adjustable toprovide a variety of height and lateral angles, and is not limited toincremental positions. The implant can be used to promote fusion, and/orto correct deformities such as scoliosis, kyphosis, andspondylolisthesis.

The clinical goals of the SEC and the method for its insertion provide aminimally invasive risk of trauma to nerve roots, reduce pain, improvefunction, and permit early mobilization of the patient after fusionsurgery. The fixation elements maintain the implant in a desiredposition until healing (fusion or arthrodesis) occurs. At this point,the implant is incorporated inside bone and its role becomes quiescent.The present SEC provides more internal and external graft bone spaceexposure, easier and safer directed insertion, less risk of insertionaldamage to nerve roots and other tissue, and thus provide substantiallyimproved immediate and long term results.

Thus, a key feature of the invention is that an essentiallyincompressible implant can be inserted posteriorly between vertebralpedicles in only a 1 cm working space. The implant then can be expandedto about 100% to about 200%, typically about 160%, of its originalinsertion size to provide a closely controlled full range of spinalcorrection in three dimensions. The one or more expandable fixationelements or spikes ensure that the implant remains in place afterdeployment. These and other advantages of the invention will become moreapparent from the following detailed description and the accompanyingexemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts placement of an SEC embodying features of the inventionbetween adjacent lumbar vertebrae.

FIG. 2 is a front perspective view of the SEC shown in FIG. 1 in anunexpanded state prior to deployment.

FIG. 3 is a sectional view of the SEC shown in FIG. 2.

FIG. 4 is a front perspective view of the SEC of similar to that shownin FIG. 2 in an expanded configuration.

FIG. 5 is a partial sectional view of the expanded SEC shown in FIG. 4in place adjacent to a vertebral body with the pointed ends of afixation member penetrating the surface of the vertebral body.

DETAILED DESCRIPTION

FIG. 1 illustrates location of spinal implant or SEC between adjacentlumbar vertebrae in an expanded configuration. A partial or completediscectomy is performed prior to the insertion of the spinal implant 10in a conventional manner. The SEC 10 is introduced in its unexpandedstate to enable it to be inserted posteriorly with minimal trauma to thepatient and risk of injury to nerve roots. Once in place the SEC 10 canbe expanded to provide both medial and lateral spinal correction. TheSEC has an unexpanded height of about 5 to about 15 mm, typically about10 mm and is expandable to at least 130% to about 180% of the unexpandedheight. Typically the SEC is about 9 to about 15 mm, typically about 12mm wide and about 25 to about 40 mm, typically about 28 mm long tofacilitate posterior insertion and thereby minimize trauma to thepatient and risk of injury to nerve roots.

FIG. 2 illustrate the SEC 10 in a closed or unexpanded configuration andFIG. 3 illustrates the SEC 10 in an expanded configuration in section orcutaway view to show the interior structure.

FIG. 4 illustrates the SEC 10 in an expanded configuration.

As shown in these figures, the SEC 10 has a base 12 with a pressureapplying end member or plate 13 having a surface for engaging an endsurface of an adjacent vertebral body. Extendable support members 15 and16 cooperate with the base 12. A second end pressure applying member orplate 17 is coupled to the extendable support members 15 and 16 so thatthe plate 17 moves with the extension of extendable support members 15and 16. The plate 17 may be fixed to only one of the extendable supportmember but also engageable with the other extendable support member.Each extendable support member may have a separate end plate fixedthereto. As shown in more detail in FIG. 3, the extendable supportmembers 15 and 16 are provided with fixation elements or spikes 18 and19 which are slidably disposed within the bores 20 and 21 of extendablesupport members 15 and 16. The spikes 18 and 19 are provided withenlarged bases 22 and 23 which provide a seal with the bores 20 and 21.The seal allows extension of the spikes 18 and 19 to be extended withthe same pressurized hydraulic fluid (not shown) which extends theextendable support members 15 and 16. The spikes 18 and 19 are providedwith pointed distal tips 22 and 23 which extend through passageways 24and 25 provided in the end pressure plate 17 to ensure contact betweenthe spikes and the adjacent vertebral body as shown in FIG. 5 so as tofix the SEC 10 within the space between the adjacent vertebral bodies.In FIG. 5, the SEC 10 is shown in the expanded configuration. The SEC 10has a central cavity 27 for infusion of bone graft material into theintervertebral space when the SEC is fully expanded or during theexpansion process.

Additional details of the SEC such as the attachment of hydraulic linesand lines for transmission of a slurry or liquid bone graft material,device and hydraulic fluid delivery accessories and the like can befound in co-pending application Ser. No. 11/535,432 filed on Sep. 26,2006 and Ser. No. 11,692,800, filed on Mar. 28, 2007, which areincorporated herein by reference.

Since vertebral end plates are held together at one end by a ligamentmuch like a clamshell, expansion of the device against the end plates ofadjacent vertebral bodies can be adjusted to create the desiredanterior/posterior correction angle.

The hydraulic fluid used to expand the SEC 10 and to extend the spikes18 and 19 may advantageously be a time-controlled curable polymer suchas methylmethacrylate. The viscosity and curing time of such a polymercan be adjusted by the formulation with an appropriate added catalyst asis well known. Such catalysts are available from LOCTITE Corp., 1001Trout Brook Crossing, Rocky Hill, Conn. 06067. When the polymer cures,it hardens and locks the extendable members 15 and 16 and the spikes 18and 19 in a desired position to provide the desired amount of spinalcorrection determined by the physician. Other means may be employed tolock the extendable members and the spikes in a desired position. Forexample, spring actuated locking fingers may be provided in the bore ofone or more of the pistons and one or more of the bores of the spikeswhich extend outwardly when the piston or spike pass their respectivelocations upon extension thereof.

It will be appreciated that the SEC, including its various componentsshould be formed of biocompatible, substantially incompressible materialsuch as titanium, and preferably type 6-4 titanium alloy or othersuitable materials which will allow for long term deployment within apatient.

The extension of extendable members 15 and 16 are preferablyindividually controlled so that the physician is able to provide acontrolled angle of the SEC corrective surface. While only twoextendable members are described herein, the SEC 10 may be provided withthree or more individually extendable members so that the physician canexercise three-dimensional control of the SEC extension.

The SEC 10 embodying features of the invention provides advantages thatinclude correction of coronal plane deformity; introduction of interbodylordosis, early stabilization of the interbody space with rigidity thatis greater than present spacer devices and the ability to fix the SECwithin the intervertebral space. This early stability may improvepost-operative pain, preclude the need for posterior implants includingpedicle screws, and improve the rate of successful arthrodesis.Importantly, the SEC provides improvement of space available for theneural elements while improving lordosis. As infusedosteoinductive/osteoconductive bone graft materials heal, the patientbecomes well and the implant becomes inert and quiescent, embedded inbone, and no longer needed.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not limited to thedisclosed embodiments and alternatives as set forth above, but on thecontrary is intended to cover various modifications and equivalentarrangements included within the scope of the following claims.

For example, the SEC 10 described herein is expanded by hydraulic fluid.Other expansion means may be employed. For example, a screw mechanismmay be employed to expand the SEC and to extend one or more of thespikes into engagement with adjacent vertebral surfaces. Additionally,the spikes which help fix the SEC within the vertebral space aredescribed herein as being extended with the extendable support members.However, the spikes may be slidably disposed in separate bores andindependent expansion of the extendable support members.

Further, the SEC can be provided with load or pressure sensors thatregister differential pressure and pressure intensity exerted on theengaging surfaces of the SEC by the patient's vertebrae end plates togenerate corrective signals, for example by control, that are used e.g.by the surgeon or by a computer controlled mechanism to realign thepatient's spine. The invention may further include a system that makesthese adjustments, responsive to sensor signals, in real time and on acontinual basis, such that the shapes of the implant changes to realignthe patient's spine or mechanism. Preferably, such system iscontemplated for use in setting the positions of the pistons duringinstallation of the implant.

Furthermore, the SEC needs not be rigidly locked into position but maybe provided with yieldable material to provide some movement of the endsurfaces of the SEC to accommodate spinal movement.

While particular forms of the invention have been illustrated anddescribed herein, it will be apparent that various modifications andimprovements can be made to the invention. Additional details of thespinal implant devices may be found in the patents and applicationsreferenced herein. To the extent not otherwise disclosed herein,materials and structure may be of conventional design.

Moreover, individual features of embodiments of the invention may beshown in some drawings and not in others, but those skilled in the artwill recognize that individual features of one embodiment of theinvention can be combined with any or all the features of anotherembodiment. Accordingly, it is not intended that the invention belimited to the specific embodiments illustrated. It is thereforeintended that this invention be defined by the scope of the appendedclaims as broadly as the prior art will permit.

Terms such as “element”, “member”, “component”, “device”, “means”,“portion”, “section”, “steps” and words of similar import when usedherein shall not be construed as invoking the provisions of 35 U.S.C.§112(6) unless the following claims expressly use the terms “means for”or “step for” followed by a particular function without reference to aspecific structure or a specific action. All patents and all patentapplications referred to above are hereby incorporated by reference intheir entirety.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

What is claimed is:
 1. (canceled)
 2. A spinal implant for placement in aspace between opposed first and second vertebral bodies, the implantcomprising: a first surface for engaging a first vertebral body; atleast two second surfaces for engaging a second vertebral body; and atleast two extendable fixation elements, each having a distal tip, acontracted configuration within the implant to facilitate deployment ofthe implant between the first and second vertebral bodies, and anextended configuration to extend the distal tip beyond one of the atleast two second surfaces to engage the second vertebral body and to fixthe implant within the space between the first and second vertebralbodies.
 3. The implant of claim 2, wherein the at least two extendablefixation elements are independently extendable.
 4. The implant of claim3, wherein the at least two extendable fixation elements are laterallyspaced apart from one another to define a central cavity in at least thecontracted configuration between the at least two extendable fixationelements, the first surface, and the at least two second surfaces, thecavity configured to receive bone graft material for infusion from thecavity into the space between the vertebral bodies.
 5. The implant ofclaim 2, wherein the first surface for engaging the first vertebral bodyincludes a base member and the at least two second surfaces for engagingthe second vertebral body include at least two pressure applyingmembers, wherein at least two support members cooperate with the baseand are each coupled to one of the at least two pressure applyingmembers.
 6. The implant of claim 5, wherein the at least two extendablefixation elements and the at least two support members are adapted to beextended by fluid.
 7. The implant of claim 6, wherein the fluidcomprises a curable polymer having a fluid state for providing hydraulicmechanical force to extend the extendable fixation elements to engage avertebral body.
 8. The implant of claim 3, wherein each of the at leasttwo pressure applying members has at least one passageway through whichthe distal tip of each extendable fixation element extends to engage thesecond vertebral body.
 9. The implant of claim 8, wherein eachextendable fixation element is extendable independent of one of the atleast two support members.
 10. The implant of claim 8, wherein eachextendable fixation element is slidably disposed within a bore of anextendable member.
 11. The implant of claim 8, wherein: the base memberdefines at least two cylinders configured to sealingly receive the atleast two support members; the central cavity is defined between the atleast two cylinders, open to the space between the vertebral bodies; andthe at least two support members each define an internal cylinderconfigured to sealingly receive the extendable fixation elements. 12.The implant of claim 11, wherein at least two of the at least twosupport members are adapted to be independently extended.
 13. Theimplant of claim 11, wherein the at least two support members arecoupled to the pressure applying member with ball shaped connections.14. A spinal implant for placement in an intervertebral space betweenopposed vertebral bodies, comprising: a base member defining first andsecond spaced apart cylinders; first and second extendable membersdisposed, respectively, in the first and second cylinders; first andsecond extendable fixation elements disposed, respectively, in the firstand second extendable members; and a pressure applying plate cooperatingwith the first and second extendable members, and disposed opposite thebase member to define a central cavity configured to receive bone graftmaterial between the first and second cylinders and between the basemember and pressure applying plate, the central cavity being open at afirst end and a second end to the intervertebral space for communicationtherewith, the central cavity having an axis between the first end andthe second end transverse to the direction of extension of theextendable members.
 15. The spinal implant of claim 14, wherein: thebase member has an outer surface opposite the central cavity configuredfor engaging a surface of a vertebral body; and the pressure applyingplate has an outer surface opposite the central cavity configured forengaging a surface of a vertebral body.
 16. The spinal implant of claim15, wherein the extendable members and extendable fixation elements areextendable by fluid pressure exerted within the cylinders.
 17. Thespinal implant of claim 14, wherein the central cavity is configured forinfusion of bone graft material into an intervertebral space.
 18. Amethod of inserting and expanding an implant having a first surface forengaging a first vertebral body, at least two second surfaces forengaging a second vertebral body, and at least two extendable fixationelements each having a distal tip, a contracted configuration within theimplant and an extended configuration to extend each distal tip beyondone of the at least two second surfaces, comprising: inserting theimplant between first and second vertebral bodies; and extending eachdistal tip beyond one of the at least two second surfaces.
 19. Themethod of claim 18, wherein the extending step further comprisesindependently extending each of the distal tips to different heightsabove one of the at least two second surfaces.
 20. The method of claim18, wherein the at least two extendable fixation elements are laterallyspaced apart to define a central cavity between laterally spacedextendable fixation elements, the first surface, and the second surface,the method further comprising: infusing bone graft material into thecentral cavity.
 21. The method of claim 20, wherein the extending stepcomprises supplying hydraulic fluid to extend the at least twoextendable fixation elements.